Continuous Glucose Monitoring for Women With Gestational Diabetes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

There are a few ongoing large randomized controlled trials (RCT's) on continuous glucose monitoring (CGM) in women with gestational diabetes (GDM) powered for pregnancy outcomes. However, none of these studies included women diagnosed with early GDM. The CORDELIA trial is a Belgian-Australian open-label multi-centric RCT with 16 centers in women with GDM (including both early and late GDM). Women will be randomized 1/1 to either treatment with CGM (intervention group, Freestyle Libre 3 +) or continue with self-monitoring of blood glucose (SMBG) with glucometer in line with normal routine (control arm). The study ends at the postpartum oral glucose tolerance test (OGTT 6-24 weeks postpartum) to screen for glucose intolerance.

Eligibility criteria

Qualifiers

At least 18 years of age at the time of signing the Informed Consent Form (ICF)

Singleton pregnancy

Diagnosed with gestational diabetes before 29.6 weeks of pregnancy

Needs to be able to understand and speak Dutch, French or English.

Disqualifiers

Patient has a history of type 2 or type 1 diabetes, or presence of auto-immune antibodies for type 1 diabetes

A physical or psychological disease likely to interfere with the conduct of the study (based on the evaluation by the treating physician).

Use of medication with significant impact on glycemia (such as high dose glucocorticoids and diabetes medication such as metformin)

Participation in an interventional Trial with an investigational medicinal product or device

Trial design

Treatments tested in this trial

  • Freestyle Libre 3
  • Glucometer

Treatment groups

386 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

University Hospital, Antwerp

Collaborator

General Hospital Groeninge

Collaborator

Onze Lieve Vrouw Hospital

Collaborator

Ziekenhuis Netwerk Antwerpen (ZNA)

Collaborator

Vitaz

Collaborator

Centre Hospitalier Universitaire de Liege

Collaborator

Erasme University Hospital

Collaborator

Université Catholique de Louvain

Collaborator

University Hospital, Ghent

Collaborator

AZ Sint-Lucas Gent

Collaborator

AZ Sint-Lucas Brugge

Collaborator

AZ St Maarten Mechelen

Collaborator

Imelda Hospital, Bonheiden

Collaborator

AZ Oostende

Collaborator

Royal Prince Alfred Hospital, Sydney, Australia

Collaborator

Campbelltown Hospital/SWSLHD

Collaborator